Post-Market Clinical Study to Confirm Safety and Performance of PuraStat Absorbable Haemostatic Material for the Management of Bleeding in Liver Surgery
- Conditions
- Liver Resection
- Registration Number
- NCT03600168
- Lead Sponsor
- 3-D Matrix Europe SAS
- Brief Summary
The objective of this post-market clinical follow-up study is to collect medical information on patients implanted with PuraStat®, according to each participating institution's procedures and standards of care.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 80
Inclusion Criteria
- Male or female patient ≥ 18 years old
- Subject have been informed and understand the nature and extent of the study, agree to its provisions and have provided written approved informed consent
- Patient undergoing elective primary or redo open liver resection for hepatic colorectal metastases with a curative intent
- Subject, who, in the opinion of the Clinical Investigator, is able to understand this clinical study, cooperate with the study procedures and is willing to return for the required post-treatment follow-up.
Main
Exclusion Criteria
- Known allergy or hypersensitivity to any component of the investigational treatment PuraStat®
- Pregnant or interested in becoming pregnant during the duration of the study, or breast feeding
- Concurrent participation in another clinical study with a medical device or medicinal product with interfering endpoints
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Total Time-To-Haemostasis Intraoperatively Total Time-To-Haemostasis will be intraoperatively measured (minutes, seconds)
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
St James' University Hospital
🇬🇧Leeds, United Kingdom